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U.S. Department of Health and Human Services

Class 2 Device Recall PageWriter TC30 with out trolley Government Bundle

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 Class 2 Device Recall PageWriter TC30 with out trolley Government Bundlesee related information
Date Initiated by FirmJanuary 09, 2019
Create DateFebruary 21, 2019
Recall Status1 Open3, Classified
Recall NumberZ-0861-2019
Recall Event ID 81957
510(K)NumberK113144 
Product Classification Electrocardiograph - Product Code DPS
ProductPageWriter TC30 w/o trolley Government Bundle, Product 860355, Software revisions up to and including A.07.05.22 to evaluate the electrocardiogram of adult and pediatric patients
Code Information US31510433 US31630351 US31630352 US31630353 US51510712 US51510713 US61510947 US61630668 US61630669 US81731977 US81731978 US91511381 US91511445 USO1511461 
Recalling Firm/
Manufacturer		 Philips North America, LLC
3000 Minuteman Rd
Andover MA 01810-1032
For Additional Information ContactPhilips Customer Services
800-722-9377
Manufacturer Reason
for Recall		Philips PageWriter TC cardiograph batteries which have reached end of life may overheat, causing the case to melt and/or the device to ignite, which can cause injury to patient or nearby users.
FDA Determined
Cause 2		Use error
ActionOn December 8, 2018, Philips issued an Urgent Medical Device Correction letter to its customers, informing them of the product issue. Philips is asking customers to follow the Action to be Taken by Customer/User section of the Urgent Medical Device Correction/Field Safety Notice This includes requesting that users: Carefully read the PageWriter TC Service Manual Addendum and to review this information with all staff members who are responsible for device management of the Philips PageWriter TC cardiographs Promptly determine the number of cycles and the State of Health (SOH) on each of the affected Philips PageWriter TC cardiographs (TC20/30/50/70), as specified in the Service Manual Addendum. Replace the battery if the number of cycles is greater than 300 and/or if the SOH is less than 80. Customers are instructed to complete and return the response card provided with the notice. Philips is instructing customers that once it is determined the battery is not in need of replacement, or once the battery is replaced, the PageWriter PC Cardiograph is safe to continuing using. Philips plans to release a customer installable, software update for PageWriter TC cardiograph (TC20/30/50/70) that will provide alerts to assist users in managing the battery replacement cycle. Users will be notified when the customer installable software update is available. The software will provide notification the customer when it is time to replace the battery, based on charge-discharge cycle count and the batteries state of health (SOH).
Quantity in Commerce14
DistributionDomestic distribution nationwide. Foreign distribution worldwide.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = DPS
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